Coronary Artery DiseaseNCT02527616
An Investigation to Evaluate an Over-The-Wire FFR Infusion Microcatheter (HYPEREM™IC) for Measuring Fractional Flow Reserve (FFR)
A study testing FFR Infusion Microcatheter and standard intra-venous (IV) infusion in people with Coronary Artery Disease, run by Diasolve Ltd at 1 site in United Kingdom.
Trial summary
This is a single-blinded, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV) infusion method used for obtaining FFR measurements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- FFR Infusion Microcatheter and standard intra-venous (IV) infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to give written informed consent prior to investigation participation.
- Has given consent to undergo hospital's diagnostic or interventional coronary procedure.
- Male and female subjects aged 18 and over.
- Ability to communicate well with the investigator and to comply with the requirements of the clinical investigation.
- Prior to randomisation:
- 1. Coronary angiogram demonstrates at least one coronary stenosis of intermediate severity (40-70%), in a non-infarct related artery, which requires FFR measurement for physiological assessment.
- -
Who cannot join
- Known sensitivity to adenosine or any of its excipients
- Technically inaccessible stenosis(es)
- Acute ST segment elevation myocardial infarction (STEMI)
- Haemodynamically unstable
- Presence of any clinically significant medical condition as determined by the investigator
- Participation in another clinical investigation within the three months prior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Crossover Investigation to Evaluate and Compare the Effectiveness, Safety and Feasibility of a Novel Dedicated Over-The-Wire FFR Infusion Microcatheter (HYPEREM™IC) for Measuring Fractional Flow Reserve (FFR) Using Intra-coronary Non-weight Adjusted Adenosine Infusion With the Standard Intra-venous Administration of Adenosine, in Subjects With Intermediate Coronary Artery Stenosis.
This is a single-blinded, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV) infusion method used for obtaining FFR measurements. All subjects requiring on a clinical basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be eligible to take part in the investigation.
Read the detailed description
Coronary artery disease is the most common type of heart disease that affects millions of people worldwide. It is caused by a narrowing or blocking of the arteries (known as stenosis) due to plaque, which restricts blood flow and reduces the amount of oxygen to the heart.
Over the past decade, fractional flow reserve (FFR) measurement has been increasingly used in cardiac catheterization laboratories, providing a straightforward and readily available quantitative assessment of the functional severity of a coronary artery stenosis, as the ability of the cardiologist to discriminate between stenoses that can cause ischemia and those that are physiologically insignificant on the basis of coronary angiography alone is limited.
Measuring FFR determines the ratio between the maximum achievable blood flow in a diseased or narrowed coronary artery and the maximum blood flow in a normal coronary artery. This ratio represents the potential decrease in coronary flow distal to the coronary stenosis.
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between the coronary pressure distal to a stenosis or a diseased segment and the aortic pressure under conditions of maximum myocardial hyperemia. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.80 is generally considered to be associated with coronary ischemia and widely accepted in favour of revascularization over conservative management.
The current standard methods of measuring FFR is to insert a pressure wire into the coronary artery while the hyperaemic agent, normally adenosine, is delivered by continuous intravenous infusion via a central femoral vein, a large ante-cubital peripheral cannula or intra-coronary bolus injection.
The investigational device in this clinical investigation is an FFR catheter being developed by Diasolve Limited; a UK based medical device development company. The FFR catheter is a combined pressure wire and hyperaemic agent delivery catheter, which allows simultaneous delivery of a pressure wire and administration of the hyperaemic agent directly into the coronary ostium or most proximal section of the coronary artery, when performing a FFR measurement using currently available pressure wire systems such as Pressure Wire Certus or Prestige from St Jude Medical.
- Conditions
- Coronary Artery Disease
- Being tested
- FFR Infusion Microcatheter and standard intra-venous (IV) infusion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR Infusion Microcatheter and standard intra-venous (IV) infusionDevice
Also called HYPEREM™IC, REF: 143836-01 GTIN: 5060420320008., HYPERAEM
Cross-over design where FFR is measured twice in the same lesion using standard standard intra-venous (IV) infusion and new method
| Study group | Role | What they receive |
|---|---|---|
| IV followed by IC (investigation) | Experimental | The patient undergoes the FFR measurement with the standard measurement first followed by FFR measurement using the FFR Infusion Microcatheter Receives: Device: FFR Infusion Microcatheter and standard intra-venous (IV) infusion |
| IC (investigation) followed by IV | Experimental | The patient undergoes the FFR measurement using the FFR Infusion Microcatheter measurement first followed by measurement via the standard measurement Receives: Device: FFR Infusion Microcatheter and standard intra-venous (IV) infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with comparable FFR ratio recordings
The FFR ratio should remain constant when measured by the standard method and the investigational device.
Measured: Intraoperative
Secondary outcomes (3)
Number of participants with Adverse Events
Participants should not experience any additional adverse events during FFR ratio measurement using the investigational device than they do using the standard method.
Measured: Intraoperative
Dose of adenosine administered.
Maximum hyperaemia may be achieved with a reduced dose of adenosine using the FFR Catheter.
Measured: Intraoperative
Time to onset of maximum hyperaemia.
Maximum hyperaemia may be achieved faster using the FFR Catheter
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diasolve Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ahmed Elghamaz, MB BCh, MRCP, Principal investigator, London North West Healthcare NHS TrustPaul Wenberger, Study chair, Diasolve Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527616
- Sponsor's protocol ID
- DIAS-001-FFR
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2015
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Crossover Investigation to Evaluate and Compare the Effectiveness, Safety and Feasibility of a Novel Dedicated Over-The-Wire FFR Infusion Microcatheter (HYPEREM™IC) for Measuring Fractional Flow Reserve (FFR) Using Intra-coronary Non-weight Adjusted Adenosine Infusion With the Standard Intra-venous Administration of Adenosine, in Subjects With Intermediate Coronary Artery Stenosis.
- ClinicalTrials.gov ID
- NCT02527616
- Acronym / sponsor ID
- DIAS-001-FFR
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Diasolve LtdIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-blinded, randomised, crossover investigation comparing the investigational device using intra-coronary (IC) Adenosine infusion to the standard intra-venous (IV) infusion method used for obtaining FFR measurements. All subjects requiring on a clinical basis a pressure wire assessment of intermediate coronary artery stenosis(es) will be eligible to take part in the investigation.
Detailed description
Coronary artery disease is the most common type of heart disease that affects millions of people worldwide. It is caused by a narrowing or blocking of the arteries (known as stenosis) due to plaque, which restricts blood flow and reduces the amount of oxygen to the heart.
Over the past decade, fractional flow reserve (FFR) measurement has been increasingly used in cardiac catheterization laboratories, providing a straightforward and readily available quantitative assessment of the functional severity of a coronary artery stenosis, as the ability of the cardiologist to discriminate between stenoses that can cause ischemia and those that are physiologically insignificant on the basis of coronary angiography alone is limited.
Measuring FFR determines the ratio between the maximum achievable blood flow in a diseased or narrowed coronary artery and the maximum blood flow in a normal coronary artery. This ratio represents the potential decrease in coronary flow distal to the coronary stenosis.
FFR is easily measured during routine coronary angiography by using a pressure wire to calculate the ratio between the coronary pressure distal to a stenosis or a diseased segment and the aortic pressure under conditions of maximum myocardial hyperemia. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.80 is generally considered to be associated with coronary ischemia and widely accepted in favour of revascularization over conservative management.
The current standard methods of measuring FFR is to insert a pressure wire into the coronary artery while the hyperaemic agent, normally adenosine, is delivered by continuous intravenous infusion via a central femoral vein, a large ante-cubital peripheral cannula or intra-coronary bolus injection.
The investigational device in this clinical investigation is an FFR catheter being developed by Diasolve Limited; a UK based medical device development company. The FFR catheter is a combined pressure wire and hyperaemic agent delivery catheter, which allows simultaneous delivery of a pressure wire and administration of the hyperaemic agent directly into the coronary ostium or most proximal section of the coronary artery, when performing a FFR measurement using currently available pressure wire systems such as Pressure Wire Certus or Prestige from St Jude Medical.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV followed by IC (investigation) | Experimental | Device: FFR Infusion Microcatheter and standard intra-venous (IV) infusionThe patient undergoes the FFR measurement with the standard measurement first followed by FFR measurement using the FFR Infusion Microcatheter |
| IC (investigation) followed by IV | Experimental | Device: FFR Infusion Microcatheter and standard intra-venous (IV) infusionThe patient undergoes the FFR measurement using the FFR Infusion Microcatheter measurement first followed by measurement via the standard measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability and willingness to give written informed consent prior to investigation participation.
- Has given consent to undergo hospital's diagnostic or interventional coronary procedure.
- Male and female subjects aged 18 and over.
- Ability to communicate well with the investigator and to comply with the requirements of the clinical investigation.
- 1. Coronary angiogram demonstrates at least one coronary stenosis of intermediate severity (40-70%), in a non-infarct related artery, which requires FFR measurement for physiological assessment.
Key exclusion criteria (6 listed)
- Known sensitivity to adenosine or any of its excipients
- Technically inaccessible stenosis(es)
- Acute ST segment elevation myocardial infarction (STEMI)
- Haemodynamically unstable
- Presence of any clinically significant medical condition as determined by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR Infusion Microcatheter and standard intra-venous (IV) infusionAlso: HYPEREM™IC, REF: 143836-01 GTIN: 5060420320008., HYPERAEMCross-over design where FFR is measured twice in the same lesion using standard standard intra-venous (IV) infusion and new method | Device | IC (investigation) followed by IV, IV followed by IC (investigation) |
Primary outcome
Number of participants with comparable FFR ratio recordings
Time frame: Intraoperative
The FFR ratio should remain constant when measured by the standard method and the investigational device.
3 secondary outcomes
Number of participants with Adverse Events
Time frame: Intraoperative
Dose of adenosine administered.
Time frame: Intraoperative
Time to onset of maximum hyperaemia.
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Individual participant dataSharing planned: No. individual data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Elghamaz, MB BCh, MRCP principal investigator
London North West Healthcare NHS Trust
Paul Wenberger study chair
Diasolve Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR Infusion Microcatheter and standard intra-venous (IV) infusion in people with Coronary Artery Disease, run by Diasolve Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with comparable FFR ratio recordings (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2016.